Alcohol ConsumptionNCT04095065
Engineering an Online STI Prevention Program: RCT
A study testing itMatters, itMatters and itMatters Sexual Violence Prevention and itMatters Well-being and itMatters Sexual Violence Prevention in people with Alcohol Consumption and Sexually Transmitted Diseases, run by Penn State University at 4 sites in United States.
Trial summary
The overall objective of the proposed research is to reduce the incidence of sexually transmitted infections (STIs) among college students. The investigators propose to accomplish this by using the innovative, engineering-inspired multiphase optimization strategy (MOST) to develop a highly effective, appealing… Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Consumption, Sexually Transmitted Diseases
- What is being tested?
- itMatters, itMatters and itMatters Sexual Violence Prevention and itMatters Well-being and itMatters Sexual Violence Prevention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,098 participants
- Where
- 4 sitesUnited States
- Study dates
- 15 Jul 2019to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Currently enrolled at an American college or University
- A first-year college student
- 18 years or older
- Have not gone through previous versions of itMatters
Who cannot join
- Not a first year student or transfer student
- Younger than 18 years old
- Have gone through previous versions of itMatters
Trial locations and contacts
4 sites in 1 country.
United States4 sites
North Dakota State University
Fargo, North Dakota, 58108
Fresno State University
Fresno, California, 93740
University of North Carolina - Greensboro
Greensboro, North Carolina, 27412
Middle Tennessee State University
Murfreesboro, Tennessee, 37132
About this study
Official title: The Intersection of Alcohol and Sex: Engineering an Online STI Prevention Program
The overall objective of the proposed research is to reduce the incidence of sexually transmitted infections (STIs) among college students. The investigators propose to accomplish this by using the innovative, engineering-inspired multiphase optimization strategy (MOST) to develop a highly effective, appealing, economical, and readily scalable internet-delivered behavioral intervention targeting the intersection of alcohol use and sexual risk behavior. The rate of STIs on college campuses is alarming: one in four college students is diagnosed with an STI at least once during their college experience. Sexual activity when drinking alcohol is highly prevalent among college students. Alcohol use is known to contribute to the sexual risk behaviors that are most responsible for the transmission of STIs, namely unprotected sex, contact with numerous partners, and "hook-ups" (casual sexual encounters). Few interventions have been developed that explicitly target the intersection of alcohol use and sexual risk behaviors, and none have been optimized. In order to reduce the incidence of STI transmission among this and other high-risk groups, a new approach is needed. MOST is a comprehensive methodological framework that brings the power of engineering principles to bear on optimization of behavioral interventions. MOST enables researchers to experimentally test the individual components in an intervention to determine their effectiveness, indicating which components need to be revised and re-tested. Given the high rates of alcohol use and sex among college students, the college setting provides an ideal opportunity for intervening on alcohol use and sexual risk behaviors. The proposed study will include a diverse population of college students on 4 campuses which will increase the generalizability of the findings. The specific aims are to (1) develop and pilot test an initial set of online intervention components targeting the link between alcohol use and sexual risk behaviors, (2) use the MOST approach to build an optimized preventive intervention, and (3) evaluate the effectiveness of the newly optimized preventive intervention using a fully powered randomized controlled trial (RCT). This work will result in a new, more potent behavioral intervention that will reduce the incidence of STIs among college students in the US, and will lay the groundwork for a new generation of highly effective STI prevention interventions aimed at other subpopulations at risk.
Read the detailed description
As part of the MOST approach, the investigators have conducted two optimization trials (NCT02897804 and NCT 03408743) to identify the optimized intervention. The current study is the randomized controlled trial of the optimized intervention.
- Conditions
- Alcohol Consumption, Sexually Transmitted Diseases
- Being tested
- itMatters, itMatters and itMatters Sexual Violence Prevention, itMatters Well-being and itMatters Sexual Violence Prevention, itMatters Well-being
- Keywords
- Multiphase optimization strategy (MOST), College students
- Medical subject headings
- Alcohol Drinking, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
itMattersBehavioural
Increase knowledge related to STIs, STI risk, alcohol impairment, condom use, alcohol use behavior tracking skill, testing \& treatment knowledge. Correct misperceptions regarding approval (injunctive norms) and prevalence (descriptive norms) of alcohol misuse \& sexual risk taking.
itMatters and itMatters Sexual Violence PreventionBehavioural
Increase knowledge related to STIs, STI risk, alcohol impairment, condom use, alcohol use behavior tracking skill, testing \& treatment knowledge. Correct misperceptions regarding approval (injunctive norms) and prevalence (descriptive norms) of alcohol misuse \& sexual risk taking. Additionally, increased knowledge related to sexual violence (prevalence, key definitions, individual rights and responsibilities, laws) and increased knowledge, efficacy, and intentions to use bystander behaviors during moments of sexual violence.
itMatters Well-being and itMatters Sexual Violence PreventionBehavioural
Increase knowledge related to sleep, including biological effects of sleep and sleep hygiene. Increase knowledge related to time management, including important definitions, sleep management strategies, and effective time management routines. Additionally, increased knowledge related to sexual violence (prevalence, key definitions, individual rights and responsibilities, laws) and increase knowledge, efficacy, and intentions to use bystander behaviors during moments of sexual violence.
itMatters Well-beingBehavioural
Increase knowledge related to sleep, including biological effects of sleep and sleep hygiene. Increase knowledge related to time management, including important definitions, sleep management strategies, and effective time management routines.
| Study group | Role | What they receive |
|---|---|---|
| itMatters | Experimental | Participants will have access to content focused on general knowledge and injunctive and descriptive norms for a period up to 3 weeks. Receives: Behavioral: itMatters |
| itMatters and itMatters Sexual Violence Prevention | Experimental | Participants will have access to content focused on general knowledge and injunctive and descriptive norms related to alcohol use and sex. Additionally, participants will have access to content focused on sexual violence including basic information and bystander intervention. This content will be available for a period up to 3 weeks. Receives: Behavioral: itMatters and itMatters Sexual Violence Prevention |
| itMatters Well-being and itMatters Sexual Violence Prevention | Experimental | Participants will have access to content focused on basic information related to sleep wellness and time management. In Addition, participants will have access to content focused on sexual violence including basic information and bystander intervention. This content will be available for a period up to 3 weeks. Receives: Behavioral: itMatters Well-being and itMatters Sexual Violence Prevention |
| itMatters Well-being | Experimental | Participants will have access to content focused on basic information related to sleep wellness and time management. This content will be available for a period up to 3 weeks. Receives: Behavioral: itMatters Well-being |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unprotected behavior at most recent vaginal or anal sex collected via online questionnaire
Two items ask whether or not a condom was used for vaginal or anal sex, for those who indicated recently having vaginal or anal sex. The variables will be reported as prevalence of this behavior and likely used as a dichotomous variable (unprotected/protected) in regression analyses.
Measured: Condom use will be assessed 60 days post-intervention.
Penetrative sex at most recent hookup collected via online questionnaire
This item asks whether or not the most recent hookup included vaginal or anal sex. This will be reported as prevalence of the behavior and likely used as a dichotomous variable in regression analyses.
Measured: This measure will be assessed 60 days post-intervention
Attitudes about sexual violence
Four items ask about perceptions of sexual violence, including language, consent, pressure, and inappropriate touching. The scale will reflect the average perceptions of sexual violence attitudes.
Measured: This measure will be assessed 60 days post-intervention.
Secondary outcomes (2)
Injunctive norms about the intersection of alcohol and sex
This scale consists of 5 items reflecting the average perceived approval of the alcohol and sex behaviors, ranging from strongly disapprove to strongly approve.
Measured: This measure will be assessed 60 days post-intervention.
Descriptive norms about the intersection of alcohol and sex
This scale consists of 5 items reflecting the average perceived prevalence of the alcohol and sex behaviors.
Measured: This measure will be assessed 60 days post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2019
- Study start15 Jul 2019
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol ConsumptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 3,098 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Collaborators
- University of North Carolina, Greensboro
- Responsible party
- Sponsor
- Investigators
- Linda M Collins, PhD, Principal investigator, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04095065
- Sponsor's protocol ID
- R01AA02931-3
- Status last verified
- Oct 2025
- First submitted
- 17 Sep 2019
- Last updated
- 7 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tanner AE, Guastaferro KM, Rulison KL, Wyrick DL, Milroy JJ, Bhandari S, Thorpe S, Ware S, Miller AM, Collins LM. A Hybrid Evaluation-Optimization Trial to Evaluate an Intervention Targeting the Intersection of Alcohol and Sex in College Students and Simultaneously Test an Additional Component Aimed at Preventing Sexual Violence. Ann Behav Med. 2021 Nov 18;55(12):1184-1187. doi: 10.1093/abm/kaab003.
PubMed 33704366
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Intersection of Alcohol and Sex: Engineering an Online STI Prevention Program
- ClinicalTrials.gov ID
- NCT04095065
- Acronym / sponsor ID
- R01AA02931-3
- Conditions
- Alcohol Consumption, Sexually Transmitted Diseases
- Keywords
- Multiphase optimization strategy (MOST), College students
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,098 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Collaborators
- University of North Carolina, Greensboro
- Study start
- 15 Jul 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 19 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall objective of the proposed research is to reduce the incidence of sexually transmitted infections (STIs) among college students. The investigators propose to accomplish this by using the innovative, engineering-inspired multiphase optimization strategy (MOST) to develop a highly effective, appealing, economical, and readily scalable internet-delivered behavioral intervention targeting the intersection of alcohol use and sexual risk behavior. The rate of STIs on college campuses is alarming: one in four college students is diagnosed with an STI at least once during their college experience. Sexual activity when drinking alcohol is highly prevalent among college students. Alcohol use is known to contribute to the sexual risk behaviors that are most responsible for the transmission of STIs, namely unprotected sex, contact with numerous partners, and "hook-ups" (casual sexual encounters). Few interventions have been developed that explicitly target the intersection of alcohol use and sexual risk behaviors, and none have been optimized. In order to reduce the incidence of STI transmission among this and other high-risk groups, a new approach is needed. MOST is a comprehensive methodological framework that brings the power of engineering principles to bear on optimization of behavioral interventions. MOST enables researchers to experimentally test the individual components in an intervention to determine their effectiveness, indicating which components need to be revised and re-tested. Given the high rates of alcohol use and sex among college students, the college setting provides an ideal opportunity for intervening on alcohol use and sexual risk behaviors. The proposed study will include a diverse population of college students on 4 campuses which will increase the generalizability of the findings. The specific aims are to (1) develop and pilot test an initial set of online intervention components targeting the link between alcohol use and sexual risk behaviors, (2) use the MOST approach to build an optimized preventive intervention, and (3) evaluate the effectiveness of the newly optimized preventive intervention using a fully powered randomized controlled trial (RCT). This work will result in a new, more potent behavioral intervention that will reduce the incidence of STIs among college students in the US, and will lay the groundwork for a new generation of highly effective STI prevention interventions aimed at other subpopulations at risk.
Detailed description
As part of the MOST approach, the investigators have conducted two optimization trials (NCT02897804 and NCT 03408743) to identify the optimized intervention. The current study is the randomized controlled trial of the optimized intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| itMatters | Experimental | Behavioral: itMattersParticipants will have access to content focused on general knowledge and injunctive and descriptive norms for a period up to 3 weeks. |
| itMatters and itMatters Sexual Violence Prevention | Experimental | Behavioral: itMatters and itMatters Sexual Violence PreventionParticipants will have access to content focused on general knowledge and injunctive and descriptive norms related to alcohol use and sex. Additionally, participants will have access to content focused on sexual violence including basic information and bystander intervention. This content will be available for a period up to 3 weeks. |
| itMatters Well-being and itMatters Sexual Violence Prevention | Experimental | Behavioral: itMatters Well-being and itMatters Sexual Violence PreventionParticipants will have access to content focused on basic information related to sleep wellness and time management. In Addition, participants will have access to content focused on sexual violence including basic information and bystander intervention. This content will be available for a period up to 3 weeks. |
| itMatters Well-being | Experimental | Behavioral: itMatters Well-beingParticipants will have access to content focused on basic information related to sleep wellness and time management. This content will be available for a period up to 3 weeks. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Currently enrolled at an American college or University
- A first-year college student
- 18 years or older
- Have not gone through previous versions of itMatters
Key exclusion criteria (3 listed)
- Not a first year student or transfer student
- Younger than 18 years old
- Have gone through previous versions of itMatters
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| itMattersIncrease knowledge related to STIs, STI risk, alcohol impairment, condom use, alcohol use behavior tracking skill, testing \& treatment knowledge. Correct misperceptions regarding approval (injunctive norms) and prevalence (descriptive norms) of alcohol misuse \& sexual risk taking. | Behavioural | itMatters |
| itMatters and itMatters Sexual Violence PreventionIncrease knowledge related to STIs, STI risk, alcohol impairment, condom use, alcohol use behavior tracking skill, testing \& treatment knowledge. Correct misperceptions regarding approval (injunctive norms) and prevalence (descriptive norms) of alcohol misuse \& sexual risk taking. Additionally, increased knowledge related to sexual violence (prevalence, key definitions, individual rights and responsibilities, laws) and increased knowledge, efficacy, and intentions to use bystander behaviors during moments of sexual violence. | Behavioural | itMatters and itMatters Sexual Violence Prevention |
| itMatters Well-being and itMatters Sexual Violence PreventionIncrease knowledge related to sleep, including biological effects of sleep and sleep hygiene. Increase knowledge related to time management, including important definitions, sleep management strategies, and effective time management routines. Additionally, increased knowledge related to sexual violence (prevalence, key definitions, individual rights and responsibilities, laws) and increase knowledge, efficacy, and intentions to use bystander behaviors during moments of sexual violence. | Behavioural | itMatters Well-being and itMatters Sexual Violence Prevention |
| itMatters Well-beingIncrease knowledge related to sleep, including biological effects of sleep and sleep hygiene. Increase knowledge related to time management, including important definitions, sleep management strategies, and effective time management routines. | Behavioural | itMatters Well-being |
Primary outcome
Unprotected behavior at most recent vaginal or anal sex collected via online questionnaire
Time frame: Condom use will be assessed 60 days post-intervention.
Two items ask whether or not a condom was used for vaginal or anal sex, for those who indicated recently having vaginal or anal sex. The variables will be reported as prevalence of this behavior and likely used as a dichotomous variable (unprotected/protected) in regression analyses.
Penetrative sex at most recent hookup collected via online questionnaire
Time frame: This measure will be assessed 60 days post-intervention
This item asks whether or not the most recent hookup included vaginal or anal sex. This will be reported as prevalence of the behavior and likely used as a dichotomous variable in regression analyses.
Attitudes about sexual violence
Time frame: This measure will be assessed 60 days post-intervention.
Four items ask about perceptions of sexual violence, including language, consent, pressure, and inappropriate touching. The scale will reflect the average perceptions of sexual violence attitudes.
2 secondary outcomes
Injunctive norms about the intersection of alcohol and sex
Time frame: This measure will be assessed 60 days post-intervention.
Descriptive norms about the intersection of alcohol and sex
Time frame: This measure will be assessed 60 days post-intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2025.
- Derived from this study: PubMed 33704366Tanner AE, Guastaferro KM, Rulison KL, Wyrick DL, Milroy JJ, Bhandari S, Thorpe S, Ware S, Miller AM, Collins LM. A Hybrid Evaluation-Optimization Trial to Evaluate an Intervention Targeting the Intersection of Alcohol and Sex in College Students and Simultaneously Test an Additional Component Aimed at Preventing Sexual Violence. Ann Behav Med. 2021 Nov 18;55(12):1184-1187. doi: 10.1093/abm/kaab003.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linda M Collins, PhD principal investigator
Penn State University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing itMatters, itMatters and itMatters Sexual Violence Prevention and itMatters Well-being and itMatters Sexual Violence Prevention in people with Alcohol Consumption and Sexually Transmitted Diseases, run by Penn State University at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unprotected behavior at most recent vaginal or anal sex collected via online questionnaire (time frame: Condom use will be assessed 60 days post-intervention.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04095065, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2025.